At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 18 enrolled
Drug / intervention
OC-01 (varenicline) nasal spray +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-Center, Randomized, Controlled, Masked Clinical Trial to Evaluate the Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation (The IMPERIAL Study)
In Brief
A Phase 2 clinical trial evaluating OC-01 (varenicline) nasal spray and Placebo (vehicle control) nasal spray for Dry Eye Disease. Completed, enrolled 18 participants across 1 site.
Detailed Summary
The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo in simulating Goblet Cell and Meibomian Gland function in adult subjects with DED.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
Enrollment StartSep 2018
First PostedSep 2018
Primary CompletionSep 2019
TodayJul 2026
First PostedSep 28, 2018
Enrollment StartSep 25, 2018
Primary CompletionSep 30, 2019
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 7.8 years ago
Interventions
OC-01 (varenicline) nasal spraydrug
OC-01 (varenicline) nasal spray
Placebo (vehicle control) nasal spraydrug
Placebo